510(k) · Cleared
ClearedSpacelabs Model 90201 Holter Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs, Inc. · DSH Recorder, Magnetic Tape, Medical
Cleared on Feb 14, 1985 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Feb 14, 1985
- Review
- 56 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK844940 Spacelabs Model 90201 Holter RecorderSpacelabs, Inc. · 1985
- Descendant · cites it directly · 2 of its ownK962930 Spacelabs Medical Ecg Analysis SystemSpacelabs Medical, Inc. · 1997
- Descendant · 2 generations on · 1 of its ownK063490 Spacelabs Medical Full Disclosure System, Model 91810Spacelabs Medical, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 0 of its ownK110779 Spacelabs Smart Disclosure SystemSpacelabs Healthcare · 2011 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K962930Spacelabs Medical Ecg Analysis SystemSpacelabs Medical, Inc. · 1997 · cites it directly2descendants
- K063490Spacelabs Medical Full Disclosure System, Model 91810Spacelabs Medical, Inc. · 2007 · 2 generations on1descendant
- K110779Spacelabs Smart Disclosure SystemSpacelabs Healthcare · 2011 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K844940 | Spacelabs Model 90201 Holter Recorder | Spacelabs, Inc. | 1985 | — |
| +1 | K962930 | Spacelabs Medical Ecg Analysis System | Spacelabs Medical, Inc. | 1997 | — |
| +2 | K063490 | Spacelabs Medical Full Disclosure System, Model 91810 | Spacelabs Medical, Inc. | 2007 | 1 |
| +3 | K110779 | Spacelabs Smart Disclosure System | Spacelabs Healthcare | 2011 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DSH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DSH device
- #1 K260157 LifeLens Physiological Monitorscore 17.9 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962930 | Spacelabs Medical Ecg Analysis System | 1997 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K962930 (Spacelabs Medical, Inc., 1997) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSH
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSH
No recall names DSH since 2007.
Adverse event reports per year · DSH
213in 2025
MAUDE reports naming product code DSH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 84 | 0 | 1 |
| 2010 | 2 | — | 0 | 8 |
| 2011 | 6 | 64 | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 3 | 91 | 0 | 31 |
| 2018 | 3 | 269 | 0 | 30 |
| 2019 | 3 | 30 | 0 | 76 |
| 2020 | 4 | 122 | 0 | 91 |
| 2021 | 4 | 263 | 0 | 113 |
| 2022 | 4 | 427 | 0 | 46 |
| 2023 | 6 | 198 | 0 | 65 |
| 2024 | 2 | — | 0 | 88 |
| 2025 | 4 | 205 | 0 | 213 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K844940 · printed Nov 4, 2026
Cite this page
510(k) Report. “K844940: Spacelabs Model 90201 Holter Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K844940
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026